Transcript Slide 1

REPORT ON
ACTIVITIES IN
AFRICA FOR 2009
CITI SPRING
MEETING
Presented by
rof. Ifeoma Okoye, President, Association for Good Clinical Practice in Nigeria (AGCPN)
rofessor of Radiology, College of Medicine, University of Nigeria, Nsukka & University of Nigeria
eaching Hospital (UNTH) Enugu, Nigeria
AFRICAN COORDINATOR OF CITI (Collaborative Institutional Training Initiative)
ASSOCIATION FOR GOOD CLINICAL
PRACTICE IN NIGERIA (AGCPN)
• an initiative that has been promoting
responsible conduct of Human Research and
developing the infrastructure for clinical trials
in Nigeria through government-regulatory
body advocacy /media sensitisation,
conferences and training workshops.
• an umbrella organisation networking
investigators/clinical trialists in Nigeria
Association for Good Clinical Practices in Nigeria
(AGCPN)
(www.agcpn.org )
conducted Annual
capacity building
National training
workshops in
Nigeria for the
past 4 years
Over 250 GCP
sensitized
potential
investigators
DEARTH OF INFLOW OF RCTS
• 100,000 clinical trials are carried out worldwide each
year, of the total; only about 10% of them is performed
in the developing countries, 1% in Africa and very
minimal fraction performed in Nigeria
• Available data show that out of the 1600 clinical trials
conducted in Africa only about 1% is placed in Nigeria
as compared to about 50% placed in South Africa, 6%
in Egypt, 55% in Uganda and 3.9% in Kenya.
• Nigeria has not had significant HIV/AIDS trials like other
countries in Eastern/Southern Africa
Clinical Trial Capacity: Large Headroom in Africa
Relatively low level of drug development activities in Africa
Clinical Trial Capacity: Large Headroom in Nigeria
Ample headroom for expansion
Diseases Represented In Ongoing Clinical Trials In Nigeria Is A
Reflection Of:
Problems of
reproductive
health
CNS
Cardiovascular
Acute
infectious
diseases
Nutritional
diseases
Cancer
Diabetes
Others
Epidemiologic Transition
Diseases of developed world
Diseases of developing countries
Changing Disease Patterns
3 ACTIVITIES SINCE LAST CITI MTG
25-26 Nov.
Sept 2008, facilitated a
‘3- Zonal ‘TOT
Workshop in
partnership with Pfizer
inc. USA thus creating
a 'Pool of 30 ‘InCountry Faculty' to
drive the proposed
regular 6-regional
AGCPN On-site
workshops
2008, United Nations
Conference Center,
Addis Ababa, Ethiopia,
UNECA( United
Nations Economic
Commission),
convened a follow up
Expert Meeting on the
AfroGuide
Project:Developing a
Harmonized Guideline
for Health Research in
Africa
The Research
Continuum in Natural
Products Drug
Discovery on May 1214th 2009 Abuja,
Nigeria by National
Institute of Allergy
and Infectious
Diseases, NIH US Dept
Health and Human
Services and NIPRD
Distribution of AGCPN members that
are enrolled into the CITI Program.
AFTER 2 YEARS ONLY 17
HAVE COMPETED
173 AGCPN REGISTERED
MEMBERS WITH
PASSWORD TO DO CITI
156 REMAIN CHALLENGED
4
INSTITUTIONS
HAVE
REGISTERED
WITH CITI
THE 4 REGISTERED INSTITUTIONS &
the buy 4 get 1 free
University of
Nigeria Teaching
Hospital, ItukuOzalla. (UNTH)
Nnamdi Azikiwe
University
Teaching Hospital,
Nnewi. (NAUTH).
National
Orthopaedic
Hospital, Enugu.
(NOHE).
Ebonyi State
University,
Abakaliki. (EBSU)
University of
Nigeria Nsukka.
(UNN)
Reasons advanced for this
poor compliance
Slow and scarcely available
internet access…
Makes the course laborious!
(? IRB IN NOH)
With dearth of research
inflow into the country, no
perceived benefits to
training.
No mandatory requirement
of training by sponsors
before becoming a PI
THE 4 INSTITUTIONS HAVE
NO CUSTOMIZED SITES
DEVELOPED FOR THEM YET
IDEALY AGCPN WOULD LIKE TO
Annual ‘on-site’ regional
trainings in 6
Use the CITI web-based
representative Geopolitical regions in Nigeria training as both a Starter
and Refresher Course for
such trainees
Participants at the opening
ceremony of the Enugu Zonal
ToT
As AGCPN continues its
advocacy to influence
political will and
commitment of policy
makers to
• Legislate and make
mandatory RCR/GCP
/Ethics/Bioethics
Education for its research
scientific community.
• Invest in strengthening
agencies like regulatory
bodies,
National/Institutional
Ethics committees, and
GCP initiatives through
properly voted
BUDGETRY ALLOCATION
HOW CAN YOU HELP?
TO INCREASE
AFRICAN
SCIENTIST
USAGE OF
CITI
FORSTER
COLABORATION
S WITH OUR
REGISTERED
INSTITUTIONS
YOUR
ORGANIZATION
CAN
TO ENGAGE IN
MULTICENTRE
RESEARCH
ASSIST TO
CUSTOMIZE
THE SITE FOR
THE 4
REGISTERED
INSTITUTIONS
Table 1: Registered Clinical Trials in Nigeria. Data culled from http://clinicaltrials.gov.
1
2
3
4
5
Title
Conditions
Trial of SAVVY Vaginal
Gel and HIV in Nigeria
Cellulose Sulfate (CS)
Gel and HIV in Nigeria
HIV Infections
Abuja Heart Study:
Prospective
Epidemiologic
Investigation of
Cardiovascular Diseases
Epidemiologic and
Molecular Features of
Cervical Cancer in
Nigeria - Project Itoju
(Care)
Pulmonary Hypertension
in Patients With Sickle
Cell Disease in Nigeria
Cardiovascular Diseases; High Blo
od Pressure
Chlamydia Infections; Gonorrhoea;
HIV Infections
Status
Recruiting
Terminated
b/c of safety
concerns
Not yet
recruiting
Cervical Cancer; Cervical Intraepith Recruiting
elial Neoplasia;
Human Papillomavirus Infection
Pulmonary Hypertension;
Secondary Pulmonary
Arterial Hypertension; Sickle Cell D
isease
Recruiting
Table 1: Registered Clinical Trials in Nigeria. (Continued)
Genetics of Type 2
Diabetes in West Africans
Use of Oral Probiotics as
an Adjunctive Therapy to
Fluconazole in the
Treatment of Yeast
Vaginitis
Chlorproguanil-DapsoneArtesunate (CDA) Versus
Chlorproguanil-Dapsone
(LAPDAP) For
Uncomplicated Malaria
Walking Study for Stroke
Rehabilitation
Chlorproguanil-DapsoneArtesunate Versus
COARTEM For
Uncomplicated Malaria
Capecitabine as
NeoAdjuvant Therapy in
Locally Advanced Breast
Cancer
Diabetes; Hypertension; Nephrop
athy; Obesity; Retinopathy
Recruiting
Vaginal Candidiasis
Recruiting
Malaria
Completed
Stroke
Recruiting
Malaria
Completed
Breast Cancer
Recruiting
Table 1: Registered Clinical Trials in Nigeria. (Continued)
Study of Tenofovir
Disoproxil Fumarate
(TDF) for Prevention of
HIV
Evaluation of 4
Artemisinin-Based
Combinations for Treating
Uncomplicated Malaria in
African Children
Genetics of Type 2
Diabetes Among Han
Chinese
Luteal v. Follicular Phase
Surgical Oophorectomy &
Tamoxifen in
Premenopausal Women
With Metastatic Hormone
Receptor + Br. CA
Measurement of Digital
Colposcopy for
Fluorescence
Spectroscopy of Cervical
Intraepithelial Neoplasia
HIV Infection
Completed
Fever; Malaria
Active, Notrecruiting
Diabetes; Hypertension; Nephrop
athy; Obesity; Retinopathy
Recruiting
Breast Cancer
Recruiting
Cervical Cancer
Completed
Table 1: Registered Clinical Trials in Nigeria. (Continued)
Evaluation of Safety and
Efficacy of ArtemetherLumefantrine Tablets in
African Infants and
Children With
Uncomplicated P.
Falciparum Malaria
Comparing Methotrexate
Followed by Misoprostol to
Misoprostol Alone for Early
Abortion
Primary Vaccination
Course in Children
Receiving the
Pneumococcal Vaccine
GSK 1024850A, Zilbrix™
Hib and Polio Sabin™
Plasmodium Falciparum
Malaria
Completed
Unwanted Pregnancy
Completed
Pneumococcal Disease
Active, notrecruiting.
Combination
Chemotherapy After
Surgery in Treating
Patients With Stage I,
Stage II, or Stage III Breast
Cancer
Misoprostol for Preventing
Postpartum Hemorrhage
Breast Cancer
Recruiting
Postpartum Haemorrhage
Completed
THE TASK MAY APPEAR HERCULIAN
BUT IT IS DOABLE WITH ALL HANDS
ON DECK!